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Executive Order 14336
Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve
Signed August 13, 2025, printed at 90 FR 40223. 3 sections of substance, 1,029 words.
This order is about medicine made abroad. It backs making more drugs and parts at home.
Sec. 1. Purpose
During my first term, my Administration acted to protect the health and security of the American people by restoring capacity for domestic production of essential pharmaceutical products. Executive Order 13944 of August 6, 2020 (Combatting Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States), directed certain executive departments and agencies (agencies) to consider a variety of actions to increase their domestic procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs, as defined in section 7 of that order, and to identify supply chain vulnerabilities. The Food and Drug Administration published a list of Essential Medicines, Medical Countermeasures, and Critical Inputs in October 2020. The Office of the Assistant Secretary for Preparedness and
During my first term, my Administration acted to protect the health and security of the American people by restoring capacity for domestic production of essential pharmaceutical products. Executive Order 13944 of August 6, 2020 (Combatting Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States), directed certain executive departments and agencies (agencies) to consider a variety of actions to increase their domestic procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs, as defined in section 7 of that order, and to identify supply chain vulnerabilities. The Food and Drug Administration published a list of Essential Medicines, Medical Countermeasures, and Critical Inputs in October 2020. The Office of the Assistant Secretary for Preparedness and
This recalls a 2020 order. That order aimed to make key medicines here. It told agencies to buy more from home producers. Countermeasures and inputs were covered too. It asked them to find weak points in supply. The drug agency then published a list in October 2020. A preparedness office did further work.
Sec. 2. Filling the SAPIR with APIs for the Most Critical Medicines
(a) Within 30 days of the date of this order, the ASPR shall develop a list, in consultation with agencies with scientific expertise, the Assistant to the President for Economic Policy (APEP), and the Assistant to the President and Homeland Security Advisor (APHSA), of approximately 26 drugs that are especially critical to the health and security interests of the Nation (the critical drugs) and an accounting of existing, available funds that can be utilized, consistent with statutory authorities, to finance the preparation and opening of the SAPIR repository and to obtain and maintain the 6-month supply of APIs for the critical drugs referenced in subsection (c) of this section shall be provided to the Director of the Office of Management and Budget (OMB). The OMB shall provide assistance to the Secretary [[Page 40224]] of Health and Human Services to facilitate the repurposing of
(a) Within 30 days of the date of this order, the ASPR shall develop a list, in consultation with agencies with scientific expertise, the Assistant to the President for Economic Policy (APEP), and the Assistant to the President and Homeland Security Advisor (APHSA), of approximately 26 drugs that are especially critical to the health and security interests of the Nation (the critical drugs) and an accounting of existing, available funds that can be utilized, consistent with statutory authorities, to finance the preparation and opening of the SAPIR repository and to obtain and maintain the 6-month supply of APIs for the critical drugs referenced in subsection (c) of this section shall be provided to the Director of the Office of Management and Budget (OMB). The OMB shall provide assistance to the Secretary [[Page 40224]] of Health and Human Services to facilitate the repurposing of
This starts a drug ingredient reserve. A preparedness office has 30 days. It must list about 26 critical drugs. Science agencies advise. Two White House aides advise too. It must also count funds already on hand. Those funds open the store. They also buy six months of ingredients. The budget office gets that report.
Sec. 3. Ensuring SAPIR Resilience
(a) Within 90 days of the date of this order, the ASPR shall provide the APHSA, the APEP, and the OMB with an update to the ASPR's 2022 list of 86 essential medicines and medical countermeasures, along with a plan to: (i) obtain from domestic manufacturers, where possible; (ii) store; and (iii) maintain a 6-month supply of APIs for drugs on the updated essential medicines list if they have not already been addressed in the list of critical drugs identified pursuant to section 2(a) of this order. (b) The plan provided pursuant to subsection (a) of this section shall include a proposal and cost estimate for opening a second SAPIR repository in the United States within 1 year of the date of this order.
(a) Within 90 days of the date of this order, the ASPR shall provide the APHSA, the APEP, and the OMB with an update to the ASPR's 2022 list of 86 essential medicines and medical countermeasures, along with a plan to: (i) obtain from domestic manufacturers, where possible; (ii) store; and (iii) maintain a 6-month supply of APIs for drugs on the updated essential medicines list if they have not already been addressed in the list of critical drugs identified pursuant to section 2(a) of this order. (b) The plan provided pursuant to subsection (a) of this section shall include a proposal and cost estimate for opening a second SAPIR repository in the United States within 1 year of the date of this order.
This widens the reserve. The office has 90 days for an update. It revisits a 2022 list of 86 key medicines. It must plan how to buy from home producers. Storage must be planned. Six months of ingredients is the target. Drugs already on the critical list are skipped. A second store is proposed within a year.
Sec. 4. General Provisions
Every order carries this. It is not what the order does.
(a) Nothing in this order shall be construed to impair or otherwise affect: (i) the authority granted by law to an executive department or agency, or the head thereof; or (ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals. (b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations. (c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person. [[Page 40225]] (d) The costs for publication of this order shall be borne by the Department of Health and Human Services. <GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT> (Presidential Sig.) THE WHITE
(a) Nothing in this order shall be construed to impair or otherwise affect: (i) the authority granted by law to an executive department or agency, or the head thereof; or (ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals. (b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations. (c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person. [[Page 40225]] (d) The costs for publication of this order shall be borne by the Department of Health and Human Services. <GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT> (Presidential Sig.) THE WHITE
This is the closing clause that nearly every order carries. It says the order does not change what the law already allows. It also says no one can sue to enforce it.
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